Healthy Learning Mind
| ISRCTN | ISRCTN18642659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18642659 |
| Protocol serial number | N/A |
| Sponsor | Folkhälsan Research Center/University of Helsinki (Dept of Public Health) (Finland) |
| Funders | Folkhälsan Research Center, Helsingin Yliopisto, Signe ja Ane Gyllenbergin Säätiö, Juho Vainion Säätiö, Mats Brommels Foundation, Yrjö Jahnssonin Säätiö |
- Submission date
- 05/10/2015
- Registration date
- 13/10/2015
- Last edited
- 17/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The transition into adulthood is a period of rapid change which can be very stressful. There is a great deal of pressure on teenagers, from teachers, their parents and even their peers. It is thought that many teenagers are not able to cope with stressful situations as well as adults. Becoming overloaded with stress can trigger serious mental health problems such as anxiety or depression. The amount of under-18s with mental health problems is growing, and effective ways of coping with stress could help to keep the situation under control. One of the best ways of dealing with stress is by learning ways to cope with the everyday situations that can be stressful. There are many ways of doing this such as learning to become more aware of yourself and the environment around you (mindfulness) and relaxation techniques so that situations that would normally be stressful are less so. The aim of this study is to find out whether teaching school age children mindfulness or relaxation techniques can improve their well-being and help them learn ways of coping with stress.
Who can participate?
Students in grades 6-8 of participating schools, their parents and teachers.
What does the study involve?
Participating schools are randomly allocated to three groups. Students attending schools in the first group, take part in a nine week mindfulness programme, which has been specially designed to help them to be more aware of their own feelings and what is going on around them. These students are also given mindfulness exercises to practise at home. Students attending schools in the second group take part in a nine week programme called “Relax”, which is designed to teach relaxation skills and emphasising the connection between mind, body and spirit (holistic approach). This programme involves both group sessions and exercises they can do at home. Students attending schools in the third group continue as normal and do not take part in any programmes in the study period. Participants take questionnaires at the start of the study, after 9 weeks, 6 months and 12 months to test their emotional well-being and coping skills (emotional resilience). Parents and teachers of participants also complete questionnaires about any changes in the students.
What are the possible benefits and risks of participating?
Possible benefits are that mindfulness and emotional well-being may improve among participants. There are no risks of participating in the study.
Where is the study run from?
Schools located in southern Finland
When is the study starting and how long is it expected to run for?
January 2014 to May 2016
Who is funding the study?
1. Folkhälsan Research Center (Finland)
2. University of Helsinki (Finland)
3. Signe and Ane Gyllenberg Foundation (Finland)
4. Juho Vainio Foundation (Finland)
5. Mats Brommels Foundation (Sweden)
6. Yrjö Jahnsson Foundation (Finland)
Who is the main contact?
Mrs Salla-Maarit Volanen
Contact information
Scientific
Topeliuksenkatu 20
Helsinki
00250
Finland
| Phone | +358 (0)50 54 21 085 |
|---|---|
| salla-maarit.volanen@helsinki.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized control study with three study arms |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Cluster-randomized controlled trial on the comparative effectiveness of a school-based mindfulness and relaxation interventions on stress resilience, mental health and well-being among 12-15 year old students |
| Study objectives | The mindfulness intervention program will better promote stress-resilience, mental health and well-being among participants compared to a standard relaxation program in a school context. |
| Ethics approval(s) | University of Helsinki Ethical review board, 07/02/2014, ref: 1/2014 |
| Health condition(s) or problem(s) studied | Health promotion |
| Intervention | Participating schools are randomly allocated to the intervention group, the control group or the non-treatment group: Intervention group: Participants take part in a nine week mindfulness programme designed for adolescents aged 11-18 years. The programme consists of nine group sessions once a week and mindfulness home practices designed to improve emotional awareness, sustained attention, and attentional and emotional regulation. Control group: Participants receive a standardised relaxation program called “Relax”. The “Relax” programme aims to produce relaxation skills and holistic wellbeing for the control group attendants. Participants attend nine weekly sessions which are divided in two parts: relaxation exercises and group discussion about different topics e.g. stress, relaxation, smartphones upsides and downsides, sleep, exercising, food and attitude. Relaxation includes progressive muscle relaxation, a breathing exercise, visualisation, “choose your emotion for rest of the day” and short brake for regaining energy. Non-treatment group: Participants are not given a programme to attend but are asked to fill out the same questionnaires as participants in the other groups at the same time points (except for the short questionnaire after the fifth lesson). The non-treatment group will receive a shorter well-being course after the one year follow-up has been conducted. Data is collected at baseline, in the middle of the intervention at the 5th session (a short questionnaire), after the intervention at 9 weeks after baseline, and 6 months after baseline from the same participants (children, their parents and teachers). Additionally, data will be collected from students 12 months after the baseline. Also a linkage to main health (or health related) registers will be done among all participating students who have given their consent for it. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Resilience is measured using the Resilience Scale (RS14) at baseline, 9 weeks, 6 months and 12 months |
| Key secondary outcome measure(s) |
Pupils: |
| Completion date | 31/05/2016 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 3000 |
| Total final enrolment | 3519 |
| Key inclusion criteria | Pupils: 1. Must be enrolled in the recruited schools (in grades 6-8) 2. Must give written consent Parents/caregivers: 1. Must be parents/caregivers of recruited students 2. Must give written consent Teachers: Must be teachers/homeroom teachers of the participating students |
| Key exclusion criteria | Severe mental health/neurological problems |
| Date of first enrolment | 01/10/2013 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00251
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 28/06/2021 | Yes | No | |
| Results article | 14/07/2022 | 02/08/2022 | Yes | No | |
| Results article | 15/12/2024 | 17/12/2024 | Yes | No | |
| Protocol article | protocol | 11/07/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/12/2024: Publication reference added.
02/08/2022: Publication reference added.
28/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
13/07/2016: Publication reference added.
